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These documents have been created/adopted by the eSubmission CMB or by the TIGes.

HMA eSubmission Roadmap

  • Final HMA eSubmission Roadmap (adopted)NEW The final version eSubmission Roadmap v.1.0 was endorsed by the EUTMB on the 1st of October 2014. Further details on the implementation of the Roadmap will be published at a later stage by the eSubmission CMB.
  • eSubmission Roadmap (powerpoint presentation) NEW The final version of the eSubmission Roadmap v.2.0 has been endorsed by the EUTMB on the 1st of October 2014. Further details on the implementation of the Roadmap will be published at a later stage by the eSubmission CMB.
  • Annex I to the HMA eSubmission Roadmap on the implementation of eCTD version 4.0. NEW This initial version of the Annex I to the roadmap was adopted by the eSubmission CMB on 17th December 2014.
  • Annex II to the HMA eSubmission Roadmap on the implementation of mandatory eCTD format for regulatory submissions.NEW This initial version of the Annex II to the roadmap was adopted by the eSubmission CMB on 17th December 2014.

TIGes Harmonised eCTD Guidance

TIGes Harmonised NeeS Guidance

EMA eSubmission Guidance for the Centralised Procedure

  • All EMA guidance documents, both practical and strategic, as well as Statements of Intent relating to eCTD and electronic submissions, can be found on the EMA external website here

Best Archiving Practice

 

EMA
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